Site KRI Overview

Study: AA-AA-000-0000

Study Status

Show Details

Description	Value
Participants Enrolled	1301
Sites Enrolled	176
Study Status	Active
protocol_row_id	1-1G9113
protocol_number	AA-AA-000-0000

Description	Value
Participants Enrolled	1301
Sites Enrolled	176
Study Status	Active
protocol_row_id	1-1G9113
protocol_number	AA-AA-000-0000
protocol_title	Protocol Title
nickname	Protocol Nickname
protocol_type	Investigator Sponsored
phase	P3
num_plan_site	190
num_site_actl	176
est_fpfv	2003-01-01
act_fpfv	2003-01-01
est_lplv	2021-06-01
act_lplv	2021-06-01
est_lpfv	2020-06-01
act_lpfv	2020-06-01
status	Active
num_plan_subj	1300
num_enrolled_subj_m	1301
protocol_indication	Protocol Indication
product	Product
therapeutic_area	Therapeutic Area
protocol_product_number	123
x_rbm_flg	Y

Study Overview

25 Red KRIs

80 Amber KRIs

As of 2024-08-06, AA-AA-000-0000 has 1301 participants enrolled across 176 sites. 25 Site-KRI combinations have been flagged across 17 sites as shown in the Study Overview Table above.

• 17 sites have at least one red KRI
• 73 sites have at least one red or amber KRI
• 179 sites have neither red nor amber KRIS and are not shown

Results

Adverse Event Rate

Summary Charts

Summary

KRI Metric

KRI Score

Serious Adverse Event Rate

Summary Charts

Summary

KRI Metric

KRI Score

Non-Important Protocol Deviation Rate

Summary Charts

Summary

KRI Metric

KRI Score

Important Protocol Deviation Rate

Summary Charts

Summary

KRI Metric

KRI Score

Grade 3+ Lab Abnormality Rate

Summary Charts

Summary

KRI Metric

KRI Score

Study Discontinuation Rate

Summary Charts

Summary

KRI Metric

KRI Score

Treatment Discontinuation Rate

Summary Charts

Summary

KRI Metric

KRI Score

Query Rate

Summary Charts

Summary

KRI Metric

KRI Score

Outstanding Query Rate

Summary Charts

Summary

KRI Metric

KRI Score

Outstanding Data Entry Rate

Summary Charts

Summary

KRI Metric

KRI Score

Data Change Rate

Summary Charts

Summary

KRI Metric

KRI Score

Screen Failure Rate

Summary Charts

Summary

KRI Metric

KRI Score

Metric Details

MetricID	File	GroupLevel	Abbreviation	Metric	Numerator	Denominator	Model	Score	Type	Threshold	nMinDenominator
kri0001	kri0001.yaml	Site	AE	Adverse Event Rate	Adverse Events	Days on Study	Normal Approximation	Adjusted Z-Score	rate	-2,-1,2,3	30
kri0002	kri0002.yaml	Site	SAE	Serious Adverse Event Rate	Serious Adverse Events	Days on Study	Normal Approximation	Adjusted Z-Score	rate	-2,-1,2,3	30
kri0003	kri0003.yaml	Site	PD	Non-Important Protocol Deviation Rate	Non-Important Protocol Deviations	Days on Study	Normal Approximation	Adjusted Z-Score	rate	-3,-2,2,3	30
kri0004	kri0004.yaml	Site	PD	Important Protocol Deviation Rate	Important Protocol Deviations	Days on Study	Normal Approximation	Adjusted Z-Score	rate	-3,-2,2,3	30
kri0005	kri0005.yaml	Site	LB	Grade 3+ Lab Abnormality Rate	Grade 3+ Abnormal Labs Samples	Total Lab Samples	Normal Approximation	Adjusted Z-Score	binary	-3,-2,2,3	30
kri0006	kri0006.yaml	Site	SDSC	Study Discontinuation Rate	Subjects Discontinued - Study	Enrolled Subjects	Normal Approximation	Adjusted Z-Score	binary	-3,-2,2,3	3
kri0007	kri0007.yaml	Site	TDSC	Treatment Discontinuation Rate	Subjects Discontinued - Treatment	Enrolled Subjects	Normal Approximation	Adjusted Z-Score	binary	-3,-2,2,3	3
kri0008	kri0008.yaml	Site	QRY	Query Rate	Queries	Total Data Points	Normal Approximation	Adjusted Z-Score	rate	-3,-2,2,3	30
kri0009	kri0009.yaml	Site	OQRY	Outstanding Query Rate	Queries Open > 30 Days	Total Queries	Normal Approximation	Adjusted Z-Score	binary	-3,-2,2,3	30
kri0010	kri0010.yaml	Site	ODAT	Outstanding Data Entry Rate	Data Pages Entered > 10 Days	Total Data Pages	Normal Approximation	Adjusted Z-Score	binary	-3,-2,2,3	30
kri0011	kri0011.yaml	Site	CDAT	Data Change Rate	Data Points with 1+ Change	Total Data Points	Normal Approximation	Adjusted Z-Score	binary	-3,-2,2,3	30
kri0012	kri0012.yaml	Site	SF	Screen Failure Rate	Screen Failures	Screened Subjects	Normal Approximation	Adjusted Z-Score	binary	-3,-2,2,3	3